Conventional adipose tissue extraction methodologies and devices typically used within research formats to study, develop, and summarize theories and or conclusions, are unsuitable for clinical application. Because of the animal derived products and non-cGMP (current good manufacturing practices) materials used in laboratory techniques during the handling and processing, use of the final products would be impermissible for human application. Advancements in tissue handling, manipulation, and processing techniques are being developed for the immediate clinical application of the processed adipose tissue materials.
In recent years, the discovery of adipose-derived stem cells in the stromal vascular fraction (SVF) of adipose tissue, specifically mesenchymal stem cells, have led to advances in tissue re-growth and differentiation. The SVF is that portion of adipose tissue other than the mature adipocytes, which can be separated after enzymatic digestion of the tissue to release individual cells from the extracellular matrix, followed by centrifugation. This fraction contains monocytes (white blood cells), erythrocytes (red blood cells), mesenchymal stem cells, committed preadipocytes, microvascular (capillary) endothelial cells, and endothelial progenitor cells. A particular future use of adipose-derived stem cells—the stromal vascular fraction, more specific to mesenchymal stem cells, could be the enhancement of the body's natural beating capabilities.
Concerns regarding clinical applications of adipose tissue derived stem cells in the medical community are based on the possibility of pathogen and xenogenic pathogen contamination due in part to fetal bovine serum or animal sera used in culture media of cells. Because of the research grade techniques used during the handling and processing of tissue samples, use of the final products would be unsuitable for human application (Preadipocytes in the human subcutaneous adipose tissue display distinct features from the adult mesenchymal and hematopoietic stem cells. Journal of Cellular Physiology 205(1):114-22, 2005 October and Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirates. Journal of Cellular Physiology 202(1): 64-76, 2006).
There is an immediate and long-felt need for methods and systems for the utilization of human tissue to be suitable for clinical application. The present invention satisfies these needs with respect to adipose tissue and adipose tissue-derived stem cells.